This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and ARM B: immediate surgery with curative intent.
This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC. After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to: * Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection). * Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection). Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks. The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
once daily afatinib at a dose of 40 mg for 8 weeks
anatomical resection and systematic lymph node dissection
Decrease in cT-stage
decrease in cT-stage descriptor measured according to RECIST 1.1
Time frame: 8 weeks
Response Rate
proportion of patients whose response is either complete response (CR) or partial response (PR) using RECIST 1.1;
Time frame: 8 weeks
Change in surgical treatment intent and technique
Time frame: 8 weeks
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